The DCGI heads the CDSCO, which comes below the jurisdiction of the Union Ministry of Well being and Family Welfare.
Repeatedly the fee has made makes an attempt to hunt particular info on the standardised and validated technique for analysing the presence of formaldehyde in child shampoo and asbestos in talcum powder manufactured and marketed by Johnson & Johnson Non-public Restricted, the summons issued by the NCPCR acknowledged.
However the acquired response from the CDSCO clearly reveals the shortage of diligence on its half to carry out its features correctly, it stated.
The NCPCR summons referred to a CDSCO letter dated March 12, 2020, which offered particulars of the testing strategies. In accordance with the letter, there is no such thing as a uniformity within the testing strategies utilized by labs to detect the presence of formaldehyde and asbestos in J&J’s merchandise.
“It’s clear from the above response (the letter) that there is no such thing as a uniformity in testing strategies for the aim of testing the presence of formaldehyde in child shampoo and asbestos in talcum powder and the identical is clearly a mandate of CDSCO to control…
“Subsequently, in view of the above, the Fee requires you to seem in individual on this matter together with related data/paperwork on 12th March, 2021 at 1200 hrs within the workplace of the Fee…,” the summons acknowledged.
The NCPCR additionally requested each the DCGI and the CDSCO as to why the latter has not regulated the requirements and ensured uniformity within the testing strategies.
It additionally sought particulars of the strategy used for testing the presence of formaldehyde and asbestos in J&J’s child shampoo and talcum powder by the Workplace of Drug Management Officer and requested why it had not been shared with the fee.
The apex youngster rights physique additionally requested whether or not the stated testing technique so used is accredited by the Indian Pharmacopoeia Fee or another authority, and why no correct info, as demanded by the NCPCR, has been offered inside the stipulated time interval regardless of numerous communications on this regard.
J&J’s child merchandise got here below the scanner in March 2019 when drug inspectors in Rajasthan claimed that that they had discovered formaldehyde in two batches of its ‘No Extra Tears’ child shampoo.
Nevertheless, later within the 12 months, the Central Medicine Laboratory (CDL), Kolkata stated it was protected to make use of the shampoo.
In 2014, US-based J&J needed to restructure the shampoo and plenty of different merchandise after considerations had been raised in regards to the presence of formaldehyde and different probably dangerous substances in them. ASG DIV